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European Commission approves ensitrelvir for COVID-19 post-exposure prophylaxis
The European Commission has approved ensitrelvir (Zokovea) for post-exposure prophylaxis (PEP) against COVID-19. This marks the first oral antiviral therapy authorized in the EU specifically for PEP, intended for use by adults and adolescents aged 12 and older following contact with infected individuals.
The decision follows the results of the global Phase 3 Scorpio-Pep study, a randomized, double-blind, placebo-controlled trial involving over 2,300 participants. In the primary analysis population, where treatment began within 72 hours of a household contact developing symptoms, ensitrelvir reduced the risk of developing symptomatic COVID-19 by 67% through day 10 compared to the placebo group.
Shionogi & Co. Ltd noted that this medication provides a new option for health emergency preparedness alongside vaccines and diagnostics. Infectious disease expert Matteo Bassetti highlighted that the approval represents a significant shift in the use of oral antivirals, moving from treating confirmed infections to providing timely intervention after known exposure to prevent symptomatic illness.
Entities
Ensitrelvir · European Commission · Matteo Bassetti · Shionogi & Co · Shionogi & Co. Ltd · Zokovea
Claims
What the coverage asserts, and how many sources carry each claim.
- [● 16 SOURCES] The Scorpio-Pep phase 3 clinical trial involved more than 2,300 participants, including adults and adolescents aged 12 and older. www.codirp.it · www.egnews.it · www.forchecaudine.com · www.messinamedica.it · www.calabrianews.it · +11 more
- [● 16 SOURCES] The European Commission has approved ensitrelvir (Zokovea) for COVID-19 post-exposure prophylaxis. www.codirp.it · www.egnews.it · www.forchecaudine.com · www.messinamedica.it · www.calabrianews.it · +11 more
- [● 16 SOURCES] In the primary analysis population, ensitrelvir reduced the risk of developing symptomatic COVID-19 by 67% through day 10 compared to a placebo. www.codirp.it · www.egnews.it · www.forchecaudine.com · www.messinamedica.it · www.calabrianews.it · +11 more
- [● 16 SOURCES] Ensitrelvir is the first oral antiviral therapy authorized in the EU for COVID-19 post-exposure prophylaxis. www.codirp.it · www.egnews.it · www.forchecaudine.com · www.messinamedica.it · www.calabrianews.it · +11 more
- [● 16 SOURCES] In the primary analysis, ensitrelvir treatment was initiated within 72 hours of symptom onset in a household contact. www.codirp.it · www.egnews.it · www.forchecaudine.com · www.messinamedica.it · www.calabrianews.it · +11 more
- [● 16 SOURCES] The Scorpio-Pep phase 3 clinical trial enrolled over 2,300 participants, including adults and adolescents aged 12 and older. www.codirp.it · www.egnews.it · www.forchecaudine.com · www.messinamedica.it · www.calabrianews.it · +11 more
- [● 16 SOURCES] Infectious disease expert Matteo Bassetti stated that the approval shifts the role of oral antivirals from treating confirmed cases to providing timely intervention after exposure. www.codirp.it · www.egnews.it · www.forchecaudine.com · www.messinamedica.it · www.calabrianews.it · +11 more
- [● 16 SOURCES] In the primary analysis population, ensitrelvir reduced the risk of symptomatic COVID-19 by 67% through day 10 compared to a placebo. www.codirp.it · www.egnews.it · www.forchecaudine.com · www.messinamedica.it · www.calabrianews.it · +11 more